Notes

Avanos Medical faces a Class I recall for its the feeding tube system that was linked to 23 deaths that occurred in 2015

The FDA has given its most severe warning regarding the recall of Avanos Medical's feed tube enteral positioning system.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet as well as an external receiver, and an LCD monitor. The system gives a live feed of medical feeding tubes that are inserted in patients' stomachs or small bowels. This allows for improvement of tip placement accuracy and reduces the risk of complications.

Avanos was not pleased with the results and announced a recall of all Cortrak*2 units between January 2021 and January 2022. The recall affected nearly 630 devices that were distributed between April 2016 & the beginning this year.

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The safety event doesn't constitute a recall in any strict sense: Avanos doesn't ask healthcare professionals for the device to be returned to the company that made it. It's simply to make sure that they're properly using them.

The incorrect placement of the feeding tube could cause injuries to the vocal cords or lungs. According to the FDA, Avanos received reports of 23 deaths, and 60 injuries, since 2015, all related to FDA's use of the Cortrak*2 system for guiding the placement of a feeding tub.

Cortrak 2 eternal access system Numerous injuries have been reported including respiratory failure (collapsed lung) as well as lung infections and holes inside the esophagus's walls.

In the March 21 field correction notice, the Georgia-based company warned users to "confirm the use of nasogastric or nasoenteric tubes according to the policies of the institution," according to the FDA. Avanos has asked users to add a safety warning to their operating manual and confirm they've updated their manuals.

Avanos has announced it will soon issue updated labeling for the device, which will include the direction to determine a tube's placement in accordance the policies of their facility prior to using the system to help install the tube.

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The FDA has issued a second warning this year regarding the use of enteral feeding tubes. Cortrak 2 eternal access system In February, the FDA released a safety communication informing healthcare professionals and parents of the risk of strangulation when children use feeding tubes.

Two deaths in 2021 were disclosed to the notice. In both instances, a tubing system was inadvertently wrapped around a child's neck when they weren't being closely monitored by hospital staff or caregivers.

"While the FDA believes that strangulation from enteral feeding tube tubing in children is unlikely to result in fatal injury or death, caregivers and healthcare providers should be aware of the potential risk," the FDA stated in the notice. Avanos Medical It also suggested that similar incidents could not have been reported to the FDA.

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Read More: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/